25OH Vitamin D Total, ELISA

The DiaSource 25OH Vitamin D Total ELISA is a competitive ELISA immunoassay, based on patented monoclonal antibodies, with a novel pre-treatment step performed inside the ELISA microtiter plate.

The novel pre-treatment step of the 25OH Vitamin D Total ELISA takes place directly in the microtiter plate. It uses a displacement reagent that displaces the 25OH Vit D from the binding proteins. The advantage of the technique is that it works at neutral pH so it can be used in the presence of the antibodies, which is not the case for the other known methods, most of them using acidic or alkaline pH.

The assay shows very competitive sensitivity, precision and performance characteristics to all other immunoassays in the market but uses a novel and extremely easy pre-treatment step performed directly in the microtiter plate. The assay is calibrated to the ID-LC-MS/MS reference method developed by Prof. Dr. Linda THIENPONT from the Ghent University in Belgium, as encompassed in the Vitamin D Standardization Program initiative. It shows a high correlation with other commercially available CLIA, LC-MS/MS and ELISA assays.

The 25OH Vitamin D Total ELISA was recently awarded the Certificate of Proficiency by the Vitamin D External Quality Assessment Scheme (DEQAS) Advisory Panel. This designation certifies that the DIAsource assay meets the performance target set by DEQAS for 25OH Vitamin D. More information on the DiaSsource DEQAS Certificate.

The novel approach of the DiaSource 25OH Vitamin D Total ELISA makes it extremely easy to program on any open ELISA platform without the need for a manual sample pre-treatment outside the ELISA automate. The assay does not require a manual transfer from extracted sample in a tube to the well in the microtiter plate.

A validated assay protocol is available on the Stratec® Gemini open ELISA automate and permits larger laboratories to easily automate their 25OH Vitamin D determinations.



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For registration requirements in countries outside of European market, please contact regulatory.affairs@diasource.be.